inotersen 284 mg/1.5 mL subcutaneous syringe

Generic name:
Inotersen - subcutaneous injection

Pronunciation
(IN-oh-TER-sen)

Brand name(s)
Tegsedi

This medication decreases the number of platelets in your blood, which may cause serious (even fatal) bleeding problems. Tell your doctor right away if you notice symptoms such as easy bruising, a rash of tiny reddish-purple spots (especially on your lower legs), bleeding gums, nosebleeds, blood in urine/stools, vomiting or coughing up blood, neck stiffness, unusual severe headache, or unusual/heavy menstrual periods (women).

This medication can cause serious kidney damage that may result in the need for dialysis. Tell your doctor right away if you have swelling in your face/feet/hands, shortness of breath, cough, blood in urine, brown/foamy urine, or change in amount of urine.

Careful monitoring and treatment by your doctor may decrease your risk for serious side effects. Lab and/or medical tests (such as kidney/liver function, complete blood count, urine tests) should be done before you start using this medication, while you are using it, and for 8 weeks after stopping treatment. Keep all medical and lab appointments.

To receive inotersen in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

This medication is used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). This condition causes a protein that your body normally makes (transthyretin-TTR), to change shape and build up in different parts of your body, which can affect the nerves, heart, eyes, and stomach/intestines. This medication works by decreasing the buildup of TTR in your body.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using inotersen and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once weekly. The injection is given in the thigh, abdomen, or upper arm. The dosage is based on your medical condition and response to treatment.

Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is bruised, tender, red, hard, or tattooed, or into scars. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, inject this medication on the same day each week.

See also Warning section.

Bruising, redness, itching, pain, or swelling at the injection site may occur. Nausea, vomiting, headache, fever, decreased appetite, numbness/tingling, or tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• back pain
• unexpected change in walking
• symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• symptoms of stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)

This medication decreases vitamin A levels in your blood. Ask your doctor about taking a vitamin A supplement. Tell your doctor right away if you develop signs of a lack of vitamin A, especially vision changes such as dry eyes, blurred vision, or trouble seeing in dim light (night blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing
• muscle/joint pain
• flushing/chills
• chest pain
• trouble swallowing
• redness on palms of your hands

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using inotersen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• kidney problems
• liver transplant

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as platelet counts), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, complete blood count, liver function, urine tests) must be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is within 2 days of the next dose, skip the missed dose. Use your next dose on your regular day. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, discard after 6 weeks. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.